Removable lung reduction devices, systems, and method

ABSTRACT

An air passageway obstruction device includes a frame structure and a flexible membrane overlying the frame structure. The frame structure is collapsible upon advancement of the device into the air passageway, expandable into a rigid structure upon deploying in the air passageway and re-collapsible upon removal from the air passageway. The flexible membrane obstructs inhaled air flow into a lung portion communicating with the air passageway. The device may be removed after deployment in an air passageway by re-collapsing the device and pulling the device proximally through a catheter.

CROSS REFERENCE TO RELATED APPLICATIONS

[0001] This is a divisional of U.S. patent application Ser. No.09/951,105, filed on Sep. 11, 2001, the entire contents of which areincorporated herein by reference.

BACKGROUND OF THE INVENTION

[0002] The present invention is generally directed to a treatment ofChronic Obstructive Pulmonary Disease (COPD). The present invention ismore particularly directed to removable air passageway obstructiondevices, and systems and methods for removing the devices.

[0003] Chronic Obstructive Pulmonary Disease (COPD) has become a majorcause of morbidity and mortality in the United States over the lastthree decades. COPD is characterized by the presence of airflowobstruction due to chronic bronchitis or emphysema. The airflowobstruction in COPD is due largely to structural abnormalities in thesmaller airways. Important causes are inflammation, fibrosis, gobletcell metaplasia, and smooth muscle hypertrophy in terminal bronchioles.

[0004] The incidence, prevalence, and health-related costs of COPD areon the rise. Mortality due to COPD is also on the rise. In 1991 COPD wasthe fourth leading cause of death in the United States and had increased33% since 1979.

[0005] COPD affects the patients whole life. It has three main symptoms:cough; breathlessness; and wheeze. At first, breathlessness may benoticed when running for a bus, digging in the garden, or walking uphill. Later, it may be noticed when simply walking in the kitchen. Overtime, it may occur with less and less effort until it is present all ofthe time.

[0006] COPD is a progressive disease and currently has no cure. Currenttreatments for COPD include the prevention of further respiratorydamage, pharmacotherapy, and surgery. Each is discussed below.

[0007] The prevention of further respiratory damage entails the adoptionof a healthy lifestyle. Smoking cessation is believed to be the singlemost important therapeutic intervention. However, regular exercise andweight control are also important. Patients whose symptoms restricttheir daily activities or who otherwise have an impaired quality of lifemay require a pulmonary rehabilitation program including ventilatorymuscle training and breathing retraining. Long-term oxygen therapy mayalso become necessary.

[0008] Pharmacotherapy may include bronchodilator therapy to open up theairways as much as possible or inhaled .beta.-agonists. For thosepatients who respond poorly to the foregoing or who have persistentsymptoms, Ipratropium bromide may be indicated. Further, courses ofsteroids, such as corticosteroids, may be required. Lastly, antibioticsmay be required to prevent infections and influenza and pheumococcalvaccines may be routinely administered. Unfortunately, there is noevidence that early, regular use of pharmacotherapy will alter theprogression of COPD.

[0009] About 40 years ago, it was first postulated that the tetheringforce that tends to keep the intrathoracic airways open was lost inemphysema and that by surgically removing the most affected parts of thelungs, the force could be partially restored. Although the surgery wasdeemed promising, the procedure was abandoned.

[0010] The lung volume reduction surgery (LVRS) was later revived. Inthe early 1990's, hundreds of patients underwent the procedure. However,the procedure has fallen out of favor due to the fact that Medicarestopping reimbursing for LVRS. Unfortunately, data is relatively scarceand many factors conspire to make what data exists difficult tointerpret. The procedure is currently under review in a controlledclinical trial. What data does exist tends to indicate that patientsbenefited from the procedure in terms of an increase in forcedexpiratory volume, a decrease in total lung capacity, and a significantimprovement in lung function, dyspnea, and quality of life. However, thesurgery is not without potential complications. Lung tissue is very thinand fragile. Hence, it is difficult to suture after sectioning. Thisgives rise to potential infection and air leaks. In fact, nearly thirtypercent (30%) of such surgeries result in air leaks.

[0011] Improvements in pulmonary function after LVRS have beenattributed to at least four possible mechanisms. These include enhancedelastic recoil, correction of ventilation/perfusion mismatch, improvedefficiency of respiratory muscaulature, and improved right ventricularfilling.

[0012] Lastly, lung transplantation is also an option. Today, COPD isthe most common diagnosis for which lung transplantation is considered.Unfortunately, this consideration is given for only those with advancedCOPD. Given the limited availability of donor organs, lung transplant isfar from being available to all patients.

[0013] In view of the need in the art for new and improved therapies forCOPD which provide more permanent results than pharmacotherapy whilebeing less invasive and traumatic than LVRS, at least two new therapieshave recently been proposed.

[0014] Both of these new therapies provide lung size reduction bypermanently collapsing at least a portion of a lung.

[0015] In accordance with a first one of these therapies, and asdescribed in U.S. Pat. No. 6,258,100 assigned to the assignee of thepresent invention and incorporated herein by reference, a lung may becollapsed by obstructing an air passageway communicating with the lungportion to be collapsed. The air passageway may be obstructed by placingan obstructing member in the air passageway. The obstructing member maybe a plug-like device which precludes air flow in both directions or aone-way valve which permits air to be exhaled from the lung portion tobe collapsed while precluding air from being inhaled into the lungportion. Once the air passageway is sealed, the residual air within thelung will be absorbed over time to cause the lung portion to collapse.

[0016] As further described in U.S. Pat. No. 6,258,100, the lung portionmay be collapsed by inserting a conduit into the air passagewaycommunicating with the lung portion to be collapsed. An obstructiondevice, such as a one-way valve is then advanced down the conduit intothe air passageway. The obstruction device is then deployed in the airpassageway for sealing the air passageway and causing the lung portionto be collapsed.

[0017] The second therapy is fully described in copending U.S.application Ser. No. 09/534,244, filed Mar. 23, 2000, for LUNGCONSTRICTION APPARATUS AND METHOD and, is also assigned to the assigneeof the present invention. As described therein, a lung constrictiondevice including a sleeve of elastic material is configured to cover atleast a portion of a lung. The sleeve has a pair of opened ends topermit the lung portion to be drawn into the sleeve. Once drawn therein,the lung portion is constricted by the sleeve to reduce the size of thelung portion.

[0018] Both therapies hold great promise for treating COPD. Neithertherapy requires sectioning and suturing of lung tissue.

[0019] While either therapy alone would be effective in providing lungsize reduction and treatment of COPD, it has recently been proposed thatthe therapies may be combined for more effective treatment. Morespecifically, it has been proposed that the therapies could beadministered in series, with the first mentioned therapy first appliedacutely for evaluation of the effectiveness of lung size reduction in apatient and which lung portions should be reduced in size to obtain thebest results. The first therapy is ideal for this as it is noninvasiveand could be administered in a physician's office. Once theeffectiveness of lung size reduction is confirmed and the identity ofthe lung portions to be collapsed is determined, the more invasivesecond mentioned therapy may be administered.

[0020] In order to combine these therapies, or simply administer thefirst therapy for evaluation, it will be necessary for at least some ofthe deployed air passageway obstruction devices to be removable.Unfortunately, such devices as currently known in the art are not suitedfor removal. While such devices are expandable for permanent deployment,such devices are not configured or adapted for recollapse after havingonce been deployed in an air passageway to facilitate removal. Hence,there is a need in the art for air passageway obstruction devices whichare removable after having been deployed and systems and methods forremoving them.

SUMMARY OF THE INVENTION

[0021] The invention provides device for reducing the size of a lungcomprising an obstructing structure dimensioned for insertion into anair passageway communicating with a portion of the lung to be reduced insize, the obstructing structure having an outer dimension which is sodimensioned when deployed in the air passageway to preclude air fromflowing into the lung portion to collapse the portion of the lung forreducing the size of the lung, the obstructing structure beingcollapsible to permit removal of the obstruction device from the airpassageway.

[0022] The invention further provides an assembly comprising a devicefor reducing the size of a lung, the device being dimensioned forinsertion into an air passageway communicating with a portion of thelung to be reduced in size, the device having an outer dimension whichis so dimensioned when deployed in the air passageway to preclude airfrom flowing into the lung portion to collapse the portion of the lungfor reducing the size of the lung, a catheter having an internal lumenand being configured to be passed down a trachea, into the airpassageway, and a retractor dimensioned to be passed down the internallumen of the catheter, seizing the device, and pulling the obstructiondevice proximally into the internal lumen to remove the device from theair passageway. The device is collapsible after having been deployed topermit the device to be pulled proximally into the internal lumen of thecatheter by the retractor.

[0023] The invention further provides a method of removing a deployedair passageway obstruction device from an air passageway in which thedevice is deployed. The method includes the steps of passing a catheter,having an internal lumen, down a trachea and into the air passageway,advancing a retractor down the internal lumen of the catheter to thedevice, seizing the device with the retractor, collapsing the device tofree the device from deployment in the air passageway, and pulling thedevice with the retractor proximally into the internal lumen of thecatheter.

[0024] The invention still further provides an air passagewayobstruction device comprising a frame structure, and a flexible membraneoverlying the frame structure. The frame structure is collapsible uponadvancement of the device into the air passageway, expandable into arigid structure upon deployment in the air passageway whereby theflexible membrane obstructs inhaled air flow into a lung portioncommunicating with the air passageway, and re-collapsible upon removalfrom the air passageway.

[0025] The invention still further provides an air passagewayobstruction device comprising frame means for forming a supportstructure, and flexible membrane means overlying the support structure.The frame means is expandable to an expanded state within an airpassageway to position the membrane means for obstructing air flowwithin the air passageway and is collapsible for removal of the devicefrom the air passageway.

BRIEF DESCRIPTION OF THE DRAWINGS

[0026] The features of the present invention which are believed to benovel are set forth with particularity in the appended claims. Theinvention, together with further objects and advantages thereof, maybest be understood by making reference to the following descriptiontaken in conjunction with the accompanying drawings, in the severalfigures of which like referenced numerals identify identical elements,and wherein:

[0027]FIG. 1 is a simplified sectional view of a thorax illustrating ahealthy respiratory system;

[0028]FIG. 2 is a sectional view similar to FIG. 1 but illustrating arespiratory system suffering from COPD and the execution of a first stepin treating the COPD condition in accordance with the present invention;

[0029]FIG. 3 is a perspective view, illustrating the frame structure ofa removable air passageway obstruction device embodying the presentinvention;

[0030]FIG. 4 is a perspective view of the complete air passagewayobstruction device of FIG. 3;

[0031]FIG. 5 is an end view of the device of FIG. 3 illustrating itsoperation for obstructing inhaled air flow;

[0032]FIG. 6 is another end view of the device of FIG. 3 illustratingits operation for permitting exhaled air flow;

[0033]FIG. 7 is a perspective view of the device of FIG. 3, illustratingits operation for permitting partial exhaled air flow;

[0034]FIG. 8 is a side view illustrating a first step in removing thedevice of FIG. 3 in accordance with one embodiment of the presentinvention;

[0035]FIG. 9 is another side view illustrating the collapse of thedevice of FIG. 3 as it is removed from an air passageway;

[0036]FIG. 10 is a side view illustrating an initial step in the removalof the device of FIG. 3 in accordance with another embodiment of thepresent invention;

[0037]FIG. 11 is a side view illustrating engagement of the framestructure of the device with a catheter during removal of the device;

[0038]FIG. 12 is a side view illustrating the collapse of the device bythe catheter during removal of the device;

[0039]FIG. 13 is a side view of another air passageway obstructiondevice embodying the present invention during an initial step in itsremoval from an air passageway;

[0040]FIG. 14 is another side view of the device of FIG. 13 illustratingits collapse during removal from the air passageway;

[0041]FIG. 15 is a perspective view of the frame structure of anotherremovable air passageway obstruction device embodying the presentinvention;

[0042]FIG. 16 is a cross-sectional side view of the device of FIG. 15shown in a deployed state;

[0043]FIG. 17 is a perspective side view of the device of FIG. 15 shownin a deployed state;

[0044]FIG. 18 is a side view illustrating an initial step in removingthe device of FIG. 15 from an air passageway;

[0045]FIG. 19 is a side view illustrating an intermediate step in theremoval of the device of FIG. 15; and

[0046]FIG. 20 is a side view illustrating the collapse of the device ofFIG. 15 during its removal from an air passageway.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0047] Referring now to FIG. 1, it is a sectional view of a healthyrespiratory system. The respiratory system 20 resides within the thorax22 which occupies a space defined by the chest wall 24 and the diaphragm26.

[0048] The respiratory system 20 includes the trachea 28, the leftmainstem bronchus 30, the right mainstem bronchus 32, the bronchialbranches 34, 36, 38, 40, and 42 and sub-branches 44, 46, 48, and 50. Therespiratory system 20 further includes left lung lobes 52 and 54 andright lung lobes 56, 58, and 60. Each bronchial branch and sub-branchcommunicates with a respective different portion of a lung lobe, eitherthe entire lung lobe or a portion thereof. As used herein, the term “airpassageway” is meant to denote either a bronchial branch or sub-branchwhich communicates with a corresponding individual lung lobe or lunglobe portion to provide inhaled air thereto or conduct exhaled airtherefrom.

[0049] Characteristic of a healthy respiratory system is the arched orinwardly arcuate diaphragm 26. As the individual inhales, the diaphragm26 straightens to increase the volume of the thorax 22. This causes anegative pressure within the thorax. The negative pressure within thethorax in turn causes the lung lobes to fill with air. When theindividual exhales, the diaphragm returns to its original archedcondition to decrease the volume of the thorax. The decreased volume ofthe thorax causes a positive pressure within the thorax which in turncauses exhalation of the lung lobes.

[0050] In contrast to the healthy respiratory system of FIG. 1, FIG. 2illustrates a respiratory system suffering from COPD. Here it may beseen that the lung lobes 52, 54, 56, 58, and 60 are enlarged and thatthe diaphragm 26 is not arched but substantially straight. Hence, thisindividual is incapable of breathing normally by moving the diaphragm28. Instead, in order to create the negative pressure in the thorax 22required for breathing, this individual must move the chest walloutwardly to increase the volume of the thorax. This results ininefficient breathing causing these individuals to breathe rapidly withshallow breaths. It has been found that the apex portion 62 and 66 ofthe upper lung lobes 52 and 56, respectively, are most affected by COPD.

[0051] In accordance with this embodiment of the present invention, COPDtreatment or evaluation is initiated by feeding a conduit or catheter 70down the trachea 28, into a mainstream bronchus such as the rightmainstem bronchus 32, and into an air passageway such as the bronchialbranch 42 or the bronchial sub-branch 50. An air passageway obstructiondevice embodying the present invention is then advanced down an internallumen 71 of the catheter 70 for deployment in the air passageway. Oncedeployed, the obstruction device precludes inhaled air from entering thelung portion to be collapsed. In accordance with the present invention,it is preferable that the obstruction device take the form of a one-wayvalve. In addition to precluding inhaled air from entering the lungportion, the device further allows air within the lung portion to beexhaled. This results in more rapid collapse of the lung portion.However, obstruction devices which preclude both inhaled and exhaled airflow are contemplated as falling within the scope of the invention.

[0052] The catheter 70 is preferably formed of flexible material such aspolyethylene. Also, the catheter 70 is preferably preformed with a bend72 to assist the feeding of the catheter from the right mainstembronchus 32 into the bronchial branch 42.

[0053]FIGS. 3 and 4 show an air passageway obstruction device 80embodying the present invention. The device 80 includes a proximal end82 and a distal end 84. The device 80 further includes a frame structure86 including frame supports 88, 90, and 92.

[0054] Each of the frame supports has a shape to define a generallycylindrical center portion 94 and a pair of oppositely extendinginwardly arcuate conical end portions 96 and 98. The frame structurefurther includes a plurality of fixation members 100, 102, and 104 whichextend distally from the proximal end 82. The fixation members have thegenerally conical shape and terminate in fixation projections or anchors106, 108, and 110 which extend radially outwardly.

[0055] Overlying and partially enclosing the frame structure 86 is aflexible membrane 112. The flexible membrane extends over the generallycylindrical and conical portions 94 and 98 defined by the framestructure. Hence, the flexible membrane is opened in the proximaldirection.

[0056] The flexible membrane may be formed of silicone or polyurethane,for example. It may be secured to the frame structure in a manner knownin the art such as by crimping, riveting, or adhesion.

[0057] The frame structure 86 and the device 80 are illustrated in FIGS.3 and 4 as the device would appear when fully deployed in an airpassageway. The frame structure supports and frame structure fixationmembers are preferably formed of stainless steel or Nitinol or othersuitable material which has memory of an original shape. The framestructure permits the device to be collapsed for advancement down theinternal lumen 71 of the catheter 70 into the air passageway where thedevice is to be deployed. Once the point of deployment is reached, thedevice is expelled from the catheter to assume its original shape in theair passageway. In doing so, the generally cylindrical portion 94contacts the inner wall of the air passageway and the fixationprojections 106, 108, and 110 pierce the wall of the air passageway forfixing or anchoring the device 80 within the air passageway.

[0058] When the device 80 is deployed, the frame structure 86 andflexible membrane 112 form an obstructing structure or one-way valve.FIGS. 5 and 6 show the valve action of the device 80 when deployed in anair passageway, such as the bronchial branch 42.

[0059] As shown in FIG. 5, during inhalation, the flexible membrane isfilled with air and expands outwardly to obstruct the air passageway 42.This precludes air from entering the lung portion being collapsed.However, as shown in FIG. 6, during expiration, the flexible membrane112 deflects inwardly to only partially obstruct the air passageway 42.This enables air, which may be in the lung portion being collapsed, tobe exhaled for more rapid collapse of the lung portion. FIG. 7 isanother view showing the device 80 during expiration with a portion 114of the membrane 112 deflected inwardly.

[0060]FIGS. 8 and 9 illustrate a manner in which the device 80 may beremoved from the air passageway 42 in accordance with one embodiment ofthe present invention. As previously mentioned, it may be desired toremove the device 80 if it is only used for evaluating the effectivenessof collapsing a lung portion or if it is found the more effectivetreatment may be had with the collapse of other lung portions.

[0061] The device 80 is shown in FIG. 8 in a fully deployed state. Thecatheter 70 having the internal lumen 71 is advanced to the proximal endof the device 80. In FIG. 8 it may be noted that the fixation members102 and 104 define a larger conical radius than the frame supports 88and 90. Hence, when the proximal end of the device is engaged by aretractor and the catheter 70 is moved distally as shown in FIG. 9, theinternal lumen of the catheter engages the fixation members 102 and 104before it engages the frame supports 88 and 90. This causes the fixationprojections to first disengage the inner wall of the air passageway 42.With the device now free of the air passageway side wall, the retractormay be used to pull the device into the internal lumen 71 of thecatheter 70 causing the support structure and thus the device tocollapse. The collapsed device may now fully enter the internal lumen ofthe catheter for removal.

[0062]FIGS. 10-12 show another embodiment of the present invention forremoving the device 80 from the air passageway 42. Here, the catheter 70is fed down a bronchoscope 118 to the device 80. The retractor takes theform of a forceps 120.

[0063] In FIG. 10 it may be seen that the forceps has just engaged theproximal end 82 of the device 80. In FIG. 11 the forceps 120 is heldstationary while the catheter 70 is advanced distally so that theinternal lumen 71 of the catheter 70 engages the fixation members 102and 104. Further advancement of the catheter 70 as seen in FIG. 12deflects the fixation projections 110 and 108 inwardly away from theinner wall of the air passageway 42. Now, the forceps may be used topull the device 80 into the internal lumen 71 of the catheter 70 forremoval of the device 80 from the air passageway 42.

[0064]FIGS. 13 and 14 show another removable air passageway obstructiondevice 130 and a method of removing it from an air passageway inaccordance with the present invention. The device 130 is shown in FIG.13 deployed in the air passageway 42 and the catheter 70 is in readyposition to remove the device 130 from the air passageway 42.

[0065] The device 130 is of similar configuration to the device 80previously described. Here however, the fixation members 136 and 138 areextensions of the frame supports 132 and 134, respectively. To that end,it will be noted in FIG. 13 that the frame supports 132 and 134 cross ata pivot point 140 at the distal end 142 of the device 130. They extenddistally and then are turned back at an acute angle to terminate atfixation or anchor ends 146 and 148. When the device is deployed asshown in FIG. 13, the cylindrical portions of the support frame engagethe inner wall of the air passageway 42 and the fixation points 146 and148 project into the inner wall of the air passageway 42 to maintain thedevice in a fixed position. The flexible membrane 150 extends from thedashed line 152 to the pivot or crossing point 140 of the frame supports132 and 134 to form a one-way valve.

[0066] When the device is to be removed, the frame structure of thedevice 130 is held stationary by a retractor within the catheter 70 andthe catheter is advanced distally. When the catheter 70 engages theframe supports 132 and 134, the frame supports are deflected inwardlyfrom their dashed line positions to their solid line positions. Thisalso causes the fixation members 136 and 138 to be deflected inwardlyfrom their dashed line positions to their solid line positions in thedirection of arrows 154. These actions disengage the device 130 from theinner wall of the air passageway 42. Now, the retractor may pull thedevice into the internal lumen 71 of the catheter 70 for removal of thedevice 130 from the air passageway 42.

[0067]FIGS. 15-17 show a still further removable air passagewayobstruction device 160 embodying the present invention. As shown in theinitial collapsed state in FIG. 15, the device 160 includes a pluralityof frame supports 162, 164, 166, and 168. The frame supports extendbetween a proximal ring 170 and a distal ring 172. The device 160 ispreferably laser cut from a sheet of Nitinol.

[0068] Since each of the frame supports are identical, only framesupport 164 will be described herein. As will be noted, the support 164includes a bend point 174 with a relatively long section 176 extendingdistally from the bend point 174 and a relatively short section 178extending proximally from the bend point 174. The short section 178includes a fixation projection or anchor 180 extending slightly distallyfrom the bend point 174.

[0069]FIGS. 16 and 17 show the device 160 in its deployed configuration.When the device is deployed, it is advanced down a catheter to itsdeployment site in its collapsed state as shown in FIG. 15. When thedeployment site is reached, the device 160 is held outside of thecatheter and the rings 170 and 172 are pulled toward each other. Thiscauses the device to bend at the bend points of the frame supports. Thisforms fixation projections 180, 182, and 184 extending into the innerwall of the air passageway to fix the device in position.

[0070] The relatively long sections of the frame supports are coveredwith a flexible membrane 186 as shown in FIGS. 16 and 17 to form aone-way valve. The valve functions as previously described to obstructinhaled air flow but to permit exhaled air flow.

[0071]FIGS. 18-20 illustrate a manner of removing the device 160 from anair passageway. Once again a catheter 70 is advanced down a bronchoscope118 to the device 160. Next, a retractor including a forceps 120 and pin190 are advanced to the device. The pin 190, carrying a larger diameterdisk 192, extends into the device as the forceps 120 grasps the proximalring 170 of the device 160. The pin 190 continues to advance until thedisk 192 engages the distal ring 172 of the device 160 as shown in FIG.19. Then, while the forceps 120 holds the proximal ring 170, the pin 190and disk 192 are advanced distally carrying the distal ring 172distally. This causes the device 160 to straighten and collapse as shownin FIG. 20. Now, the forceps 120, pin 190, and the device 160 may bepulled into the internal lumen 71 of the catheter 70 for removal of thedevice. As will be appreciated by those skilled in the art, theforegoing steps may be reversed for deploying the device 160.

[0072] While particular embodiments of the present invention have beenshown and described, modifications may be made, and it is thereforeintended in the appended claims to cover all such changes andmodifications which fall within the true spirit and scope of theinvention.

What is claimed is:
 1. An intra-bronchial valve device configured to beimplanted within an air passageway of a lung, the device comprising: aframe comprising a plurality of elongate frame supports joined to oneanother at first and second attachment points, wherein each framesupport assumes an at-rest shape with a substantially straight centerportion and a pair of oppositely extending inwardly arcuate endportions; and a flexible membrane disposed on the frame and covering atleast portions of the frame supports, the membrane being sealed to theframe to prevent airflow between a first side of the membrane and asecond side of the membrane.
 2. The device of claim 1, wherein themembrane is attached to the supports so as to preclude airflow from theconcave side to the convex side of the membrane while permitting air toflow from the convex side to the concave side along a path between themembrane and a portion of an air passageway wall.
 3. The intra-bronchialvalve of claim 1, wherein the first and second attachment points arelocated at ends of the elongate support members.
 4. The intra-bronchialvalve of claim 1, wherein the elongate support members comprise sectionsof resilient wire.
 5. The intra-bronchial valve of claim 1, wherein thefirst attachment point of the frame is configured to be engaged by aretractor device.
 6. The intra-bronchial valve of claim 5, wherein theframe is configured such that pulling the frame into a catheter lumencauses the frame to collapse.
 7. The intra-bronchial valve of claim 1,further comprising at least one anchor member extending from the firstor the second attachment point, said anchor member being configured todirectly engage a portion of the air passageway wall.
 8. Theintra-bronchial valve of claim 7, wherein the anchor member extends froma distal end of the frame.
 9. The intra-bronchial valve of claim 7,wherein the anchor member is configured to puncture portions of the airpassageway wall.
 10. An intra-bronchial valve device comprising: a framecomprising a plurality of elongate frame supports having first andsecond ends joined by at first and second common attachment points; aflexible membrane disposed on the frame and covering at least portionsof the frame supports, the membrane having a concave side and a convexside; wherein the device is configured to be implanted within an airpassageway of a patient, and wherein the membrane is attached to thesupports so as to preclude airflow from the concave side to the convexside of the membrane while permitting air to flow from the convex sideto the concave side along a path between the membrane and a portion ofan air passageway wall.
 11. The intra-bronchial valve of claim 10,wherein the frame assumes an at-rest shape with a substantiallycylindrical center portion and a pair of oppositely extending inwardlyarcuate end portions.
 12. The intra-bronchial valve of claim 10, whereinthe frame is configured to be engaged by a retractor device and to bepulled into a lumen of a removal catheter.
 13. The intra-bronchial valveof claim 12, wherein the frame is configured such that pulling the frameinto a catheter lumen causes the frame to collapse.